The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6126–6150 of 21595

  • ModerateFDA (Drugs)·D-0228-2021·2021-01-20

    Precision Dose Recalls Chlorhexidine Gluconate Oral Rinse Due to cGMP Deviations

    Precision Dose Inc. is recalling Chlorhexidine Gluconate Oral Rinse USP 0.12% unit dose cups due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2021·2021-01-20

    Ortho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides

    Ortho Clinical Diagnostics is recalling VITROS XT Chemistry Products ALB-TP Slides due to potential interference from the drug eltrombopag.

    Product
    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0230-2021·2021-01-20

    Zapien Hand Sanitizer Recalled for Sub-Potent Product

    GAZA is recalling Zapien Hand Sanitizer Gel due to cGMP deviations and sub-potent product from the same facility.

    Product
    Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0824-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Drums Recalled for Low Levels

    Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2021·2021-01-20

    Philips Recalls EPIQ and Affiniti Ultrasound Systems for Data Display Errors

    Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.

    Product
    All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2021·2021-01-20

    Clerio Vision Contact Lenses Recalled for Incorrect Power Labeling

    Clerio Vision is recalling one lot of contact lenses because the packaging labeled them as -2.25 power, but the lenses inside are -3.75 power.

    Product
    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2021·2021-01-20

    Remel Blood Agar Bi-Plate Recalled for Poor Microbial Growth

    Remel Inc is recalling 637 units of Blood Agar/MacConkey Agar Bi-Plates because the blood agar side may fail to grow certain patient isolates or quality control organisms.

    Product
    Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0860-2021·2021-01-20

    Medtronic Intellis Spinal Cord Stimulator Software Recall

    Medtronic is recalling the Intellis Spinal Cord Stimulator software due to a defect that prevents clinicians from programming the implantable neurostimulation device.

    Product
    Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0221-2021·2021-01-20

    Akorn Recalls Levetiracetam Oral Solution Due to Leaking Bottles

    Akorn, Inc. is recalling specific lots of Levetiracetam Oral Solution because customer complaints reported the liquid leaking from the bottles.

    Product
    Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0847-2021·2021-01-20

    Visby Medical Recalls 282 COVID-19 Test Kits for Labeling Errors

    Visby Medical is recalling 282 COVID-19 test kits because some boxes incorrectly state the product is CLIA Waived and some components expire before the kit expiration date.

    Product
    visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0770-2021·2021-01-13

    Ortho VITROS CKMB Slides Recalled for Potential Falsely Elevated Results

    Ortho Clinical Diagnostics is recalling VITROS CKMB Slides because CK-MM interference may cause falsely elevated creatine kinase MB results.

    Product
    VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2021·2021-01-13

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0788-2021·2021-01-13

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the outside label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0772-2021·2021-01-13

    Smith & Nephew Recalls Trigen Intertan Bone Fixation Nails for Packaging Error

    Smith & Nephew is recalling 41 units of Trigen Intertan bone fixation nails due to a manufacturing packaging error. The devices were distributed nationwide and in Australia, Canada, and the UK.

    Product
    Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2021·2021-01-13

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside.

    Product
    Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2021·2021-01-13

    Steris Recalls Vis-U-All Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0201-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 751 syringes of Morphine Sulfate 3 mg/3 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0792-2021·2021-01-13

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed after steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2021·2021-01-06

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error

    Smiths Medical is recalling 238 Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been incorrectly packaged with a V-neck flange instead of a straight flange.

    Product
    PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0756-2021·2021-01-06

    Lidco CM 50-001-01 Injectate Kit Recalled for Incorrect Expiration Date

    Lidco Ltd is recalling specific lots of the CM 50-001-01 Injectate Kit because the expiration date on the labeling is incorrect.

    Product
    CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0179-2021·2021-01-06

    Ascend Cephalexin Oral Suspension Recalled for Impurity Specification Failures

    Ascend Laboratories is recalling Cephalexin for Oral Suspension because it failed impurity and degradation specifications. The recall covers 9,524 bottles distributed nationwide.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0187-2021·2020-12-30

    Meijer Organic Green Peas Recalled for Potential Nightshade Contamination

    Meijer Distribution is recalling True Goodness Organic Green Peas because the product may contain nightshade.

    Product
    True Goodness by Meijer Organic Green Peas Frozen 10 Oz plastic bag UPC 7-08820-73708-2, 12 bags per case-pack
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0645-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect

    GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
    Category
    Medical Device
    Distribution
    Distributed nationwide